Progress and registration management of clinical research of stem cells in China
ZHANG Kai-qiang
WANG Yue
ZHONG Wei
ZHU Hua-yuan
WANG Yuan-hui
HUANG Yi-huan
JING Yuan-hao
LI Wen-wen
YE Rong
SU Yu-wen
Abstract：Stem cells are a kind of cells with the potential of self-renewal and multi-directional differentiation.Stem cell clinical research refers to infusing or implanting autologous or allogeneic stem cells into human body through in vitro operation to prevent or treat diseases.Under the active guidance of relevant policies,stem cell clinical research in China has made remarkable progress,and the registration and supervision system is becoming increasingly standardized.This paper describes the main supervision modes and registration requirements of stem cell clinical research in China and makes a systematic analysis of the situation of stem cell clinical research registration on the Drug Clinical Trial Registration and Information Disclosure Platform,the Medical Research Registration and Filing Information System,and the China Clinical Trials Registry Center in the past five years(January 1,2020 to December 31,2024).The research results are helpful for the research and development institutions of stem cell products,medical and health regulatory agencies,and the public to fully understand the development of stem cell clinical research.It also provides an important scientific basis for the establishment of quality standards for the registration and improvement of the level of scientific supervision of stem cell clinical research,as well as the decision-making on stem cell clinical transformation research.
Keywords：stem cellsclinical researchclinical trialsregistryregistrationfiling
Publication Date：2025-10-30
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：11( 2161-2171 )